The purpose of this study is to demonstrate whether use of glucarpidase facilitates administration of the next cycle of chemotherapy as scheduled and improves safety and tolerability of HDMTX given with LV

IV dose based on weight, two doses given for 5 minutes, 24 hours apart

Other Name: Voraxaze, caboxypeptidase G2, CPG2

Active Comparator: B

HDMTX-LV with placebo

Drug: leucovorin

IV or po given every 6 hours

Other Name: LV

Experimental: C

compassionate use group to treat or prevent life threatening toxicity in the event of delayed elimination of MTX and/or renal impairment

Drug: glucarpidase

IV dose based on weight, two doses given for 5 minutes, 24 hours apart

Other Name: Voraxaze, caboxypeptidase G2, CPG2

Eligibility

Ages Eligible for Study:

8 Years to 50 Years (Child, Adult)

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

osteosarcoma

eligible to receive 2 sequential cycles of HDMTX-LV

Exclusion Criteria:

prior administration of glucarpidase

progression of disease while on previous MTX treatment

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00634322